(91 days)
Not Found
No
The description focuses on computer-assisted navigation using sensors and positional information, without mentioning AI or ML algorithms for data processing or decision support.
No
The device is a surgical navigation system designed to assist surgeons in accurately positioning implants and instrumentation during knee arthroplasty procedures, rather than directly treating a disease or condition itself.
No
The device is a computer-assisted surgical navigation system designed to assist surgeons in determining reference alignment axes and facilitating the accurate positioning of implants and instrumentation during knee arthroplasty procedures. It does not diagnose medical conditions.
No
The device description explicitly states it utilizes a "palm-sized computer module and reference sensor" and mentions "System hardware verification/validation testing," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- KneeAlign System Function: The KneeAlign system is a surgical navigation system used during orthopedic procedures (specifically knee arthroplasty). It assists the surgeon in determining anatomical alignment and positioning implants and instrumentation.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens from the patient. The system relies on external measurements and calculations related to anatomical structures and surgical instruments.
Therefore, the KneeAlign system falls under the category of a surgical navigation or computer-assisted surgery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KneeAlign® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic surgical procedures. The KneeAlign system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes.
Orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
- Unicompartmental Knee Arthroplasty Tibial Transverse Resection
Product codes
OLO
Device Description
The KneeAlign® 2 System is a non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® 2 System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format.
The KneeAlign® 2 System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In total knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Operating Room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device performance testing confirms that the KneeAlign® 2 System can be used according to its intended use. The KneeAlign® 2 System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed only the added Unicompartments and surgical procedure steps. Performance testing included:
- System hardware verification/validation testing to ensure the instruments meet their mechanical requirements.
- Instrumentation cleaning, sterilization and shipping validations for the specified processes.
- Navigation device sterilization, packaging, shelf life, environmental conditions and shipping validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced.)
- System components biocompatibility assessment per ISO 10993-1 (2009).
- Customer requirements / usability validation in cadaver with an advising surgeon to validate the system meets design input requirements for its functions in a simulated use environment.
- System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy.
For simulated use testing, a prospective cadaver validation was done in a simulated operating room environment with a surgeon conducting the procedures.
This testing regime demonstrates that the subject device is as safe and effective as the predicate devices. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in the accurate navigation of tibial resection planes in unicompartmental knee arthroplasty.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OrthAlign Plus® System (K153237), KneeAlign® 2 System (K103829)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
OrthAlign, Inc. % David Vancelette Director QA/RA Orthalign, Inc. 120 Columbia, Suite 500 Aliso Viejo, California 92656
Re: K163379
Trade/Device Name: KneeAlign 2 System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 30, 2016 Received: December 1, 2016
Dear David Vancelette:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name KneeAlign 2 System
Indications for Use (Describe)
The Knee Align® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic surgical procedures. The KneeAlien system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes.
Orthopedic surgical procedures include but are not limited to:
- · Total Knee Arthroplasty
- · Unicompartmental Knee Arthroplasty Tibial Transverse Resection
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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5. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
| DATE | November 30, 2016 |
|---|---|
| APPLICANT | OrthAlign, Inc. |
| 120 Columbia | |
| Suite 500 | |
| Aliso Viejo, CA 92656 | |
| Tel: (949) 715-2424 | |
| Fax: (949) 831-9500 | |
| OFFICIAL | |
| CORRESPONDENT | David Vancelette |
| OrthAlign, Inc. | |
| 120 Columbia, | |
| Suite 500 | |
| Aliso Viejo, CA 92656 | |
| dvancelette@orthalign.com | |
| Tel: (949) 525-9034 | |
| Fax: (949) 831-9500 | |
| TRADE NAME | KneeAlign® 2 System |
| COMMON NAME | Stereotaxic Instrument |
| DEVICE | |
| CLASSIFICATION | Class II, 21 CFR §882.4560 |
| PRODUCT CODES | OLO: Orthopedic Stereotaxic Instrument |
| PREDICATE | |
| DEVICES | OrthAlign Plus® System (K153237) |
| KneeAlign® 2 System (K103829) | |
| SUBMISSION TYPE | Traditional 510(k). The subject device is a modification |
| to the previously cleared KneeAlign® 2 System | |
| (K103829). |
SUBSTANTIALLY EQUIVALENT TO:
The KneeAlign®2 System is substantially equivalent to the previously cleared KneeAlign® 2 System (K103829) and OrthAlign Plus® System (K153237).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The KneeAlign® 2 System is a non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® 2 System is configured to detect, measure, and display angular and positional measurement changes in a triaxial
4
format.
The KneeAlign® 2 System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In total knee arthroplasty procedures, the device assists the surgeon in:
- . Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.
INDICATIONS FOR USE:
The KneeAlign® 2 System has the same indications for use as the previously cleared KneeAlign® 2 System (K103829). Additional functionality has been added to the predicate device to enable the navigation of tibial transverse resections in unicompartmental knee arthroplasty. Also, Indications for Use are common to the OrthAlign Plus® System (K153237). Thus, the Indications for Use are as follows:
KneeAlign® 2 System:
The KneeAlign® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes.
Orthopedic surgical procedures include but are not limited to:
- . Total Knee Arthroplasty
- . Unicompartmental Knee Arthroplasty - Tibial Transverse Resection
TECHNICAL CHARACTERISTICS (COMPARED TO PREDICATE):
The KneeAlign® 2 System was cleared under K103829. The KneeAlign® 2 System comprises a single use computer module, a reusable reference sensor, a reusable femoral iig and a reusable tibial jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and
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anatomy on the user display screen. The KneeAlign®2 System is being updated to include navigation functionality for unicompartmental knee arthroplasty, as in the predicate device OrthAlign Plus® System (K153237). All other features and principles of operation remain unchanged.
PERFORMANCE DATA:
Device performance testing confirms that the KneeAlign® 2 System can be used according to its intended use. The KneeAlign® 2 System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed only the added Unicompartments and surgical procedure steps. Performance testing included:
- System hardware verification/validation testing to ensure the instruments meet . their mechanical requirements.
- . Instrumentation cleaning, sterilization and shipping validations for the specified processes.
- . Navigation device sterilization, packaging, shelf life, environmental conditions and shipping validations for the specified ranges of conditions involved in each process. (Summary data for the identical predicate device is referenced.)
- System components biocompatibility assessment per ISO 10993-1 (2009). ●
- Customer requirements / usability validation in cadaver with an advising ● surgeon to validate the system meets design input requirements for its functions in a simulated use environment.
- . System accuracy testing: bench testing with mechanical fixtures and foam models to verify navigated resection plane angular and depth accuracy.
For simulated use testing, a prospective cadaver validation was done in a simulated operating room environment with a surgeon conducting the procedures.
This testing regime demonstrates that the subject device is as safe and effective as the predicate devices. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in the accurate navigation of tibial resection planes in unicompartmental knee arthroplasty.
The information provided by OrthAlign in this 510(k) application confirms that the KneeAlign® 2 System is substantially equivalent to predicate devices such as the KneeAlign® 2 System (K103829) and OrthAlign Plus® System (K153237).
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technological comparison and bench and simulated use testing demonstrate the substantial equivalence of the KneeAlign® 2 System to the predicate devices.
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The subject device is identical to the predicate KneeAlign® 2 System (K103829), with the following exceptions:
- The subject device allows for the navigation of the tibial transverse resection . plane in unicompartmental knee arthroplasty.
The subject device is substantially equivalent in terms of unicompartmental knee arthroplasty function to the predicate device OrthAlign Plus® System (K153237).
The table below summarizes the features of the subject device as compared to the predicate devices.
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510(K) SUMMARY
Table 1. KneeAlign® 2 System Comparison to Predicates
| Property | KNEEALIGN® 2 SYSTEM | KNEEALIGN® 2 SYSTEM (K103829)
PREDICATE 1 | ORTHALIGN PLUS® SYSTEM (K153237)
PREDICATE 2 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Total Knee Arthroplasty /
Unicompartmental Knee Arthroplasty:
The KneeAlign® system is a computer-
controlled system intended to assist the
surgeon in determining reference
alignment axes in relation to anatomical
structures during stereotactic orthopedic
surgical procedures. The KneeAlign
system facilitates the accurate positioning
of implants and instrumentation, relative
to these alignment axes.
Orthopedic surgical procedures include
but are not limited to:
Total Knee Arthroplasty Unicompartmental Knee
Arthroplasty - Tibial
Transverse Resection | Total Knee Arthroplasty
The KneeAlign® system is a computer-
controlled system intended to assist the
surgeon in determining reference
alignment axes in relation to anatomical
structures during stereotactic orthopedic
surgical procedures. The KneeAlign
system facilitates the accurate
positioning of implants and
instrumentation, relative to these
alignment axes.
Orthopedic surgical procedures include
but are not limited to:
Total Knee Arthroplasty ▶ Unicompartmental Knee
Arthroplasty function is being
added. | Total Knee Arthroplasty / Total Hip
Arthroplasty / Unicompartmental Knee
Arthroplasty:
The OrthAlign Plus®System is a
computer-controlled system intended to
assist the surgeon in determining
reference alignment axes in relation to
anatomical and instrumentation
structures during stereotactic orthopedic
surgical procedures. The OrthAlign
Plus® System facilitates the accurate
positioning of implants, relative to these
alignment axes. The system aids the
surgeon in controlling leg length and
offset discrepancies in Total Hip
Arthroplasty.
Example orthopedic surgical procedures
include but are not limited to:
Total Knee Arthroplasty Total Hip Arthroplasty:
Anterior/Posterior Unicompartmental Knee
Arthroplasty: Tibial transverse
resection ▶ Same Indications for Use. |
| Property | KNEEALIGN® 2 SYSTEM | KNEEALIGN® 2 SYSTEM (K103829)
PREDICATE 1 | ORTHALIGN PLUS® SYSTEM (K153237)
PREDICATE 2 |
| Technological Principles | | | |
| Computer generation of
positional information | Uses inertial sensors, microcontroller and
digital signal processor to generate
positional information. | Identical | Identical |
| Registration of anatomy | Lateral and medial malleoli and the center
of the tibial plateau are registered to
establish a tibial reference frame. | Identical | Identical |
| Navigation of tibial
transverse resection plane | Posterior slope is in the sagittal plan of
the tibia. Varus/Valgus is in the coronal
plane of the tibia. | Identical | Identical |
| Controls resection depth | Via mechanical instruments | Identical | Identical |
| Surgical work flow | Patient preparation Instrument setup Instrument attachment to patient Anatomic registrations Cutting block navigation Resection | Identical | Identical |
| Design Elements | | | |
| Main System Components | Single-use computer unit Navigation software Reusable instrument set Registration instruments Cutting blocks | Identical | Identical |
| User Interface | Integrated graphical user interface, on
single-use unit that attached to
instrumentation. | Identical | Identical |
| Tibial Cutting Blocks | Mechanical instrument that interfaces
with tibial jig for variable positioning | Identical | Identical |
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